Presentation of main changes 2014 Code

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Main changes to the
ABPI Code of Practice for the
Pharmaceutical Industry
and to the
PMCPA Constitution and Procedure
Main changes to the ABPI Code

Agreed by ABPI Members 20 November 2014

To come into operation on 1 January 2015
Changes due to:

EFPIA Disclosure Code

Changes to EFPIA HCP Code

Outcome of ABPI Board Review

Regular updating/tidying up
2015 Code
Operative on 1 January 2015.
Transition period until 30 April 2015 to comply
with newly introduced provisions.
Main changes
Clause 1 Scope and
Definitions
Clause 1.1 Supplementary Information and other
consequential changes:
‘appropriate administrative staff’ replaced with
‘other relevant decision makers’ and definition
added
Main changes
Clause 1
 Reference to ‘electronic material’ and ‘social
media’ added to examples of sales promotion
 Definition of ‘healthcare organisation’ (HCO)
added
 Supplementary information to make clear that a
HCO consisting only of one health professional
or other relevant decision maker would be
subject to requirements for individual health
professionals
Main changes
Clause 1
 Exception added in the event of a conflict of
requirements with regard to the limits for
subsistence in countries where the national
association is a member of EFPIA and thus
covered by EFPIA Codes as referred to in the
supplementary information to Clause 19.2
Main changes Clause 2 Discredit to, and
Reduction of Confidence in,
the Industry
 ‘unacceptable payments’ added to the examples
of activities likely to be in breach of Clause 2
Main changes Clause 3 Advance Notification
of New Products or Product
Changes
 Additional supplementary information making it clear
advance notification relates to products which may
significantly affect expenditure and that the effect on
expenditure could be significant additional cost or savings
 Delete reference to 2-3 years in advance to meet treasury
requirements
 Additional supplementary information requiring companies
to ensure that advanced information is also provided
wherever possible for inclusion in horizon scanning
databases
Main changes Clause 4 Prescribing
Information and other
Obligatory Information
 Bullet points reordered to make it clear that the
cost where needed and the legal classification
must be provided and that either the remainder
of the current bullet points are provided or the
summary of product characteristics in order to
meet the requirements for prescribing
information
Main changes Clause 4 Prescribing
Information and other
Obligatory Information
 Clause 4.3 expanded to add similar requirements to
those in Clause 4.6 for the non proprietary name in
electronic advertising
Main changes Clause 4 Prescribing
Information and other
Obligatory Information
 New Clause requiring that for digital material such
as advertisements in electronic journals, emails,
electronic detail aids and such like, the prescribing
information may be provided either by inclusion in
the digital material itself or by way of a clear and
prominent direct single click link. Such links can
only be used when material is generally expected to
be viewed online
Main changes Clause 4 Prescribing
Information and other
Obligatory Information
 Delete Clause 4.5 relating to audio material and
requirements for advertisements in an
independently produced electronic journal as
these are now covered by other clauses
 Amend Clause 4.7 to make it clear it applies to
printed material
Main changes Clause 4 Prescribing
Information and other
Obligatory Information
 Add clarity regarding when reproducing the SPC would
not be an acceptable way to meet requirements for
prescribing information
 Add supplementary information regarding future changes
to the adverse event reporting address
 Clarify that digital communications are also covered by the
black triangle symbol and associated requirements
Main changes Clause 7.5
 Add clarity that when data from clinical trials is
used as substantiation, the trial must be
registered and the results disclosed as required
by Clause 13.1
Main changes Clause 9 High standards,
Format, Suitability and
Causing Offence, Sponsorship
 Additional supplementary information regarding the use
of inappropriate language, abbreviations or emoticons
particularly in digital communications
 Delete reference to the provision of rubber stamps to
doctors for use as aids to prescription writing
 Delete reference to defunct or superseded
organisations, the ‘Medicines Commission, the
Committee on Safety of Medicines, and the Medicines
Control Agency
Main changes Clause 9.9
 Additional supplementary information providing
clarity that similar arrangements for responding
to emails apply if the enquiry is by letter but an
email address is provided
 Additional supplementary information regarding
prior permission when detailing remotely and
associated requirements
Main changes Clause 11 Distribution of
Promotional Material
 Remove reference to promotional material. All
material sent by a company should be relevant
to the intended audience
Main changes Clause 12 Disguised
Promotion
 Add a reference to the supplementary information
regarding promotional material sent electronically
Main changes Clause 13 Non interventional
studies
 Addition of ‘and commercially available’ to provide
more guidance regarding when clinical trial results
are required to be disclosed
 Amended to refer generally to the current Joint
Positions rather than specific Joint Positions
Main changes Clause 14 Certification
 Additional supplementary information allowing
printed material to be certified electronically and
only one of the two signatories to certify the final
form
 Additional clarity regarding no need to certify
meetings which involve travel outside the UK if
the only involvement is sponsoring a speaker to
present at the meeting
Main changes Clause 14 Certification
 Clarification for certification of joint working
documents, everything used during the
development of the project should be of the same
standard as certified material but only the final
documents need to be certified
Main changes Clause 14 Certification
 Replace ‘technical’ with relevant as it is relevant
briefing material that should be certified
 Addition supplementary information regarding
certification of digital material
 Additional clarity regarding certification of joint
ventures and co-promotion
Main changes Clause 15 Representatives
 Reference to electronic material added
Main changes Clause 16 Training
 Clarification that an application for an extension
regarding the representatives exam should be
made on a form available from the PMCPA and
should preferably be made by the company
Main changes Clause 18 Items for
Patients etc
 To be headed ‘Prohibition on Inducements and
Inappropriate Payments and the Provision of
Items for Patients, Health Professionals and
Other Relevant Decision Makers Outcome
Agreements and Patient Access Schemes’
 Adjust content so that Clauses 18.4 and 18.6,
18.5 and 18.7 become three separate clauses
Main changes Clause 18
 Simplification of supplementary information re
package deals
 Update General Medical Council guidance
 Update the Pharmaceutical Price Regulation
Scheme date, reference to NICE and add
reference to devolved nations
Main changes Clause 18
 Amend the supplementary information to make
clear the differences between pens and pads at
company organised meetings and pens and
pads in conference bags. If pens and pads are
provided for conference bags at third party
organised meetings they are not allowed to
include the company name
Main changes Clause 18
 Add to the supplementary information that
transfers of value in relation to medical and
educational goods and services must be
disclosed
 Clarify certification requirements for joint working
materials
Main changes Clause 18
Clauses 18.4 and 18.6 to become Clause 19
Medical and Educational Goods and Services
Clause 18.5 to become Clause 20 Joint Working
Clause 18.7 to become Clause 21 Relationships
and Contracts with Certain Organisations
Main changes Clause 19 Meetings,
Hospitality and Sponsorship
 Updated to allow premium economy flights in
limited circumstances (flights scheduled to take
longer than six hours)
 Remove reference to PGEA approved courses
Main changes
Clause 19 Meetings,
Hospitality and Sponsorship
 Additional supplementary information clarifying
that the maximum of £75 (plus VAT and
gratuities) does not apply when a meeting is
held outside the UK in a country where the
national association is a member of EFPIA and
thus covered by EFPIA Codes. In such
circumstances the limits in the host country code
would apply
Main changes Clause 21 Transfers of
Value
 Add reference to Clause 18.4
 Clarification that the term ‘health professional’ in relation
to disclosure of transfers of value also includes any
employee of a pharmaceutical company whose primary
occupation is that of a practising health professional
 Add the requirement that a central platform for
disclosure in the UK must be used by companies
 Clarification that only payments to health professionals
can be aggregated. Payments to healthcare
organisations need to be given on an individual basis.
Clause 23
Relations with the
public and the media
Add reference to social media to the supplementary
information to Clause 23.2 Information to the
Public.
Add reference to NHS Choices, NHS III and
devolved nations to supplementary information to
Clause 23.4 Requests for Information or Advice on
Personal Medical Matters.
Clause 25 The Internet
 Add reference to the Joint Position on the
Publication of Clinical Trial Results in the
Scientific Literature
2015 Code
 Comes into operation on 1 January 2015
 Transition period until 30 April 2015 for newly
introduced requirements
Main changes Constitution and Procedure
 Complainants encouraged to provide contact
details rather than submitting anonymous
complaints.
 Reference to promotional material and
promotional activities deleted as the Code covers
more than promotion
 Delete ‘practising’ as this is now covered by
‘registered’ with regard to the independent
pharmacist on the Appeal Board
Main changes Constitution and Procedure
 Notice of appeal may now be withdrawn by a
complainant with the consent of the respondent
company at anytime but if notice is given by a
complainant company after the papers relating to
its appeal have been circulated to the Appeal
Board, then the higher administrative charge will
be payable
 Refer to the Competition and Markets Authority
instead of the Office of Fair Trading
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